Date

2024-12-18

Protocol

Protocol changed

Item Changed

Secondary outcome

Previous Version

1.Annualized rate of change in estimated glomerular filtration rate (eGFR) [Baseline, Week 52, 104 ]; 2.Serum galactose deficient IgA1 (Gd-IgA1) levels [Baseline, Weeks 36, 52, and 104 ]; 3.Composite kidney failure endpoint defined as experiencing at least one of the following during the study: • At least a 30% reduction in eGFR sustained for at least 30 days • eGFR <15 mL/min/1.73m2 sustained for at least 30 days • Chronic dialysis ?30 days • Kidney transplantation • Death from kidney failure [Over 104 weeks ]

Next Version

1. Annualized Rate of change in eGFRb (ie., annualized eGFR total slope) 2. Serum galactose deficient IgA1 (Gd-IgA1) levels 3. Composite kidney failure endpoint defined as experiencing at least one of the following during the study: • At least a 30% reduction in eGFR sustained for at least 30 days • eGFR <15 mL/min/1.73m2 sustained for at least 30 days • Chronic dialysis ?30 days • Kidney transplantation • Death from kidney failure